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Product category: Clinical chemistry analysis
News Release from: Sysmex UK | Subject: XE 2100
Edited by the Laboratorytalk Editorial Team on 19 June 2002

FDA approval for haematology HPC
parameter

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The first submitted and cleared extended differential parameter using the reclassification of automated differential cell counter

Sysmex UK has scored a first in haematology and gained FDA (Food and Drug Administration) approval for its HPC (haematopoietic progenitor cell) parameter on the XE 2100 haematology analyser This is the first submitted and cleared extended differential parameter using the reclassification of automated differential cell counter (Sec

864.5220) by the FDA (effective 13 February 2002).

With the increasing acceptance of stem cell transplantation as a standard therapy worldwide, there has been an accompanying rapid increase in demand for technologies that can detect and count progenitor (stem) cells.

The Sysmex XE 2100 is equipped with a unique IMI channel, a specially designed unit for the detection of immature myeloid cells.

The HPC parameter of the IMI channel is used as a screen for the optimal presence of haematopoietic progenitor (stem) cells in peripheral blood and cord blood samples.

Particularly suitable for all hospitals and specialised clinics (eg.

haematology and oncology) that perform peripheral blood stem cell (PBSC) transplants as a major therapy, the HPC parameter provides clinically useful information in a timely and cost effective manner.

It dramatically reduces the waiting time for progenitor cell analysis results down to 90 seconds.

Based on fluorescent flow cytometric technology, the XE 2100 is ideal for use in routine haematology laboratories for NRBC, reticulocyte differential, and Immature Reticulocyte Fraction (IRF) analyses, and the HPC parameter provides a cost-effective method of expanding the range of tests available.

HPC enumeration can be used to predict the optimal time to harvest stem cells in patients undergoing mobilisation for autologous or allogeneic stem cell transplants.

The cells are detected in the IMI channel, which uses RF/DC detection and cell specific lysis to target the lipid content of myeloid cells, separating mature from immature cells.

HPCs can be counted in their distinct cluster on the IMI scattergram.

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